Amgen Life Sciences Job – Apply Online For Sr. Associate Regulatory Affairs Post
Amgen Life Sciences Job – Apply Online For Sr. Associate Regulatory Affairs Post. Latest job opportunities for Sr. Associate Regulatory Affairs at Amgen, Interested and eligible candidates can check out all the details in the same below.
Job role: Sr. Associate Regulatory Affairs
Job Location: India – Mumbai
Career Category: Regulatory
Job Description:
Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Senior Regulatory Affairs in Mumbai, India.
About You!
The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products and may support a LRR or lead a program under the supervision of an experience Local Regulatory Lead. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.
Main Responsibilities:
- Assist in aligning local regulatory requirements with Amgen’s corporate standards.
- Contribute for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team. With close supervision, implementing the filing plan (MA and Lifecycle maintenance) for the country(ies), where applicable.
- Provide country specific / regional (as applicable) input to and implement regulatory strategies.
- Plan and lead local regulatory submissions in compliance with corporate standards and local regulatory requirements.
- Provide guidance on local mechanisms to optimize product development and regulatory approvals
- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
- Act as the point of contact with regulatory agencies.
What we expect of you
Qualifications
- Degree in Life Sciences, Pharmacy or Biomedical field and 3-5 years of relevant regulatory experience
- Knowledge of Regulatory principles.
- Working with policies, procedures, and SOP’s.
- Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.
- Good knowledge of Indian regulations on new product registration, lifecycle management and clinical trials, SUGAM portal handling.
- General awareness of the registration procedures/challenges in the country(ies) for CTAs, MAs and all lifecycle management activities.
- Knowledge and experience in the country(ies) regulatory environment relevant for product area and development stage.
- Understanding of drug development.
Thrive
What you can expect of us
As we work to develop treatments that take care of others sowork to care for our teammates’ professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Possible Interview Questions may be asked for Sr. Associate Regulatory Affairs at Amgen
1. Can you describe your experience in regulatory affairs and your knowledge of regulatory guidelines and submissions? Answer: In my previous role as an Associate Regulatory Affairs professional, I gained extensive experience in regulatory affairs. I am well-versed in regulatory guidelines, such as ICH-GCP and FDA regulations, and have successfully prepared and submitted regulatory documents, including INDs, NDAs, and annual reports. I have also collaborated with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
2. How do you stay updated with the latest changes in regulatory requirements and guidelines? Answer: Staying updated with regulatory changes is crucial in the field of regulatory affairs. I regularly monitor regulatory agencies’ websites, attend industry conferences and workshops, and actively engage with regulatory affairs networks. I am a member of professional associations, allowing me to access the latest updates and participate in discussions on evolving regulatory trends.
3. Can you describe your experience in managing regulatory submissions and interactions with regulatory agencies? Answer: I have managed multiple regulatory submissions and interactions with regulatory agencies throughout my career. This includes preparing submission dossiers, responding to queries, and coordinating meetings with regulatory authorities. I have experience in compiling, organizing, and submitting documents in compliance with regulatory guidelines and within specified timelines.
4. How do you ensure regulatory compliance during product development and post-approval phases? Answer: Ensuring regulatory compliance is a priority in every stage of product development and post-approval. I work closely with cross-functional teams to establish regulatory strategies and timelines, ensuring that regulatory requirements are met. I conduct thorough reviews of documentation and processes to ensure compliance with regulatory guidelines and standards. Additionally, I actively participate in internal and external audits to identify and address any compliance gaps.
5. How do you handle challenges or issues that arise in the regulatory affairs process? Answer: Challenges are common in the regulatory affairs process, and I approach them with a proactive and solution-oriented mindset. I prioritize effective communication and collaboration with stakeholders to address challenges and find appropriate solutions. I am adept at conducting thorough research, seeking guidance from regulatory experts, and utilizing my knowledge of regulatory guidelines to overcome challenges and ensure successful outcomes.
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